A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment. This article discusses strategies for the development, optimization, and validation of NAb assays in relation to biosimilar and originator therapeutics.
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Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
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What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
Learn how BioAgilytix provides the
See how our PK expertise complements our immunogenicity services by evaluating
Learn why we’re a trusted partner to
What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.
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